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IVC Filter – Medical Device Maker Charged with Breaking the Law

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As reported here (see article), a federal judge in Arizona has been appointed to oversee numerous lawsuits filed against C.R. Bar, Inc. arising from injuries related to its blood clot filter device known as an IVC (inferior vena cava) filter.

According to the FDA, Bard illegally sold adulterated and mis-branded IVC Filters and failing to report complications and adverse events. Starting in 2003, Bard’s own research showed that the IVC filters posed an unreasonable danger to patients from splintering. However, Bard did not warn patients or doctors, and did not tell the FDA about their findings, while continuing to distribute the profitable Recovery IVC filter. Bard wanted to wait until it could create a suitable substitute product to sell.

Bard only removed the Recovery IVC from the market when it had a new filter, the G2, ready in 2005. Since 2005, the FDA has received 921 device adverse event reports involving IVC filters. Additional FDA investigation found Bard in violation of 21 U.S.C. § 803.50(a)(2) for failure to submit a report to the FDA after Bard became aware of information, from any source, that reasonably suggests that its IVC filter devices malfunctioned and that these devices it markets would likely cause or contribute to death or serious injury if the malfunction were to recur.